Congenital Nystagmus
Conditions
Interventions
Experimental group:Implanting the Nerve-Muscle Stimulator provided by SuperVision Technology. Approximately 1 month postoperative, the device was activated and adjusted to normal stimulation parameter
Control group:Implanting the Nerve-Muscle Stimulator provided by SuperVision Technology. Approximately 1 month postoperative, the device was activated and adjusted to lowest parameters (Current Pulse
Pulse Width 65 µs
Pulse Frequency 0.1 Hz, no theoretical therapeutic effect). After obtaining study results with zero current stimulation, control group is administered using normal stimulation parameters, similar to t
Feasibility test:Implanting the Nerve-Muscle Stimulator provided by SuperVision Technology. Approximately 1 month postoperative, the device was activated and adjusted to normal stimulation parameters.
Sponsors
Beijing Chao-Yang Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 8 years old; 2. Diagnosed with congenital nystagmus; 3. Participant is able to understand the purpose of the trial, and willing to participate voluntarily; Participant is able to follow the protocol for follow-up, and consented to by the participant and/or guardian by signing an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of other organic ocular diseases. 2. Congenital cone-rod dystrophy. 3. Congenital nystagmus with macular and optic disc hypoplasia. 4. Vestibular neuropathy nystagmus. 5. Congenital ocular structural abnormalities. 6. Presence of diseases such as eye infections, otitis media, mastoiditis, etc., which is not effectively controlled. 7. Previous surgical interventions for nystagmus that may affect the efficacy or evaluation of this treatment. 8. Presence of active implants in the body, such as cardiac pacemakers, cochlear implants, or other neurostimulators. 9. Severe primary systemic diseases, such as tumors, hematological disorders, immune system diseases, etc., making the patient intolerant to implant surgery. 10. Severe mental disorders and/or severe epilepsy that affects compliance with treatment and follow-up. 11. Pregnant or lactating women. 12. Any other conditions made unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Foveation period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nystagmus amplitude;Nystagmus frequency;Visual acuity improvement;Degree of improvement or cure of abnormal head posture;NEI-VFQ-25 visual functioning questionnaire; | — |
Countries
China
Contacts
Public ContactTao Yong
Beijing Chao-Yang Hospital,Capital Medical University
Outcome results
None listed